Hi @fourdollars, thanks for your questions. I don’t usually like answering one off’s as It does take time, though in this instance I have made an exception given the veracity of the current Imugene situation. Many investors are confused at present, so perhaps these answers provide some guidance to them and those only recently invested in the stock. On that front feel free to read my previous posts, and those of @unbelievable, @davybabyk and others on this thread for additional information
WMHB said “the combination trial had no bearing whatsoever on the existing development of the Her VAXX drug”.
1. You said “We've had final PFS results that did not show any increase vs SOC”
WMHB answer :
I am buoyed by Leslie Chong unwavering support for the current Her VAXX Phase 2 trial and her consistent positive outlook when asked, queried or questioned as to the OSR, safety and efficacy pertaining to the said trial. It goes without saying many analysts see Her VAXX as being comparable if not more effective than the Roche blockbuster Herceptin, in treating Her 2 expressing cancers. Let’s look a bit closer at the Her VAXX Phase 2 trial in order to identify with Leslie’s optimism
Original Her Vaxx Results
Results: IMU-131 was safe without vaccine-related significant local/systemic reactions or serious adverse events. A total of 11 of 14 patients were evaluable for changes in tumor size and vaccine-specific immune responses. One patient showed complete, 5 partial responses, and 4 stable diseases as their best response. HER2-specific IgG levels were dose dependent. In contrast to patients in C1 and C2, all patients in C3 mounted substantial HER2-specific Ab levels. In addition, cellular vaccine responses, such as Th1-biased cytokine ratios and reduced regulatory T cell numbers, were generated. Progression-free survival was prolonged in C3, correlating with the vaccine-specific humoral and cellular responses.
Conclusions: IMU-131 was well tolerated and safe. The induced HER2-specific Abs and cellular responses were dose dependent and correlated with clinical responses. The highest dose (50 μg) was recommended for further evaluation in a phase II trial, with chemotherapy + IMU-131 or chemotherapy alone, which is currently ongoing.
Mid Term Her Vaxx Phase 2 Data
July 5, 2021 - Data presented at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer meeting showed Imugene's HER-Vaxx vaccine program showed a statistically significant overall survival of 58.2% compared to chemotherapy alone..
You asked :
Maybe not on a scientific level (although there is now at least going to be a delay), but you previously touted the "collaboration" with Merck as validation of IMU's attractiveness to BP. Would you concede that's been damaged?
WMHB answer :
The rationale behind Merck’s decision to move on from their trial with Imugene is unclear. It may have been as simple as a conflict of interest with Merck Germany. Was it a financial decision to cut additional development ependiture given the current economic climate in Europe? Is the new Merck management concerned by the fact they now expect molnupiravir’s sales for the year to fall between $5 billion and $5.5 billion, narrowing its previous guidance of $5 billion to $6 billion? I think so.
The outcome could indeed provide the incentive Imugene needs to explore further the potential of combining Her VAXX with the company’s own PD1 VAXX suite of drugs. As Professor Kaumaya suggested in the recent Science 2 Series, this combination could realise the greatest results thus far in treating cancer.
The bottom line is this was a supply agreement, not a commercial one. And for a gazetted trial, not an existing one. The world is wrought with supply chain issues at present. Is this a factor in Mercks change in plans? Imugene appears to be seeking to source the combination drug from alternate supply chains. Though irrespective of this outcome my point is that their current Phase 2 trial is still ongoing, with the cleansing of OSR sure to be taking place as we speak. The Merck decison and future Her VAXX combinations can have no bearing on the outcome of the existing Phase 2 results.
WMHB quoted :
"On a micro level, Imugene’s drugs move closer to patients, week by week."
You suggested :
I don't understand this reasoning. Its similar to previous assertions that "the fundamentals have only gotten better". I'd argue that (at least in the case of HER-Vaxx) prescribing the drug is further away from patients than it was in November 2020. Since then, we've had clear indications that:
- there is no plan for a registrational trial (even Leslie is now saying that final O/S is basically irrelevant, since all anyone is now interested in is the action of the drug. This seems to confirm that regardless of the outcome, all we'll be doing is proceeding with the new Phase II trials);
Keep in mind two factors. Firstly that patient responses to CF33 can be ascertained much faster than with other cancer drugs. Pre clinically Yuman Fong could visualise responses in mice within 30 days of treatment, if not sooner in many instances. Secondly when announcing the Merck Pfizer, Her VAXX combination trial CEO Leslie Chong stated results would be forthcoming in a short space of time, given the trial was being conducted on early stage patients.
Most importantly Imugene’s Phase 1 PD1 Vaxx trial has shown encouraging signs in treating patients with NSCLC. Whilst the interim Her Vaxx Phase 2 trial data highlights the fact the company has been effective in prolonging the lives of gastric cancer patients. I make reference to the fact that as the cohorts from PD1 VAXX, Her VAXX, and now CF33 move further and further into months of progression free survival, the path to registrational trial status becomes that much closer. For it’s a fact the FDA, regulatory and medical authorities are all searching for pathways to introduce drugs to patients in instances where an unmet need is being met.
The times they are a changin’
The length of time between bench to bedside when it comes to the time taken to develop a drug and bring it market is changing. Particularly in instances where the FDA recognises an unmet need, as is definitely the case with PD1 VAXX and non-small cell lung cancer (NSCLC). On the other side of Imugene’s B cell treatment program the Independent Review Committee’s decision to shorten the length of the current Her VAXX Phase 2 trial could exemplify such a fact.
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug development and review.
Unmet medical need:
- “is a condition whose treatment or diagnosis is not addressed adequately by available therapy.”
Hypothetical examples include:
When a drug shows an improved effect on a serious outcome compared with available therapy.
Recent real life examples include :
The US Food and Drug Administration (FDA) has granted fast track designation (FTD) to Genprex’s lead drug candidate, Reqorsa Immunogene Therapy, plus Keytruda to treat histologically confirmed unresectable stage III or IV non-small cell lung cancer (NSCLC). see PD1 Vaxx above treating NSCLC.
I do sense frustration in your tone. Given the lack of clarity surrounding existing trials, it is no doubt warranted. “When on earth are investors going to get an update on the Her VAXX Phase 2 trial? The trial had a completion date of early 2022. We are now in May. We heard about cohorts 1 and 2 in the existing PD1 trial in Australia. What is the status of Cohort 3, dosed in the US? Were they dosed? Have they disappeared? Are they all still alive? Investors are none the wiser. Is there a Chief Technical Officer present in the building who can answer these questions? If not I’m sure the ASX may well be seeking further clarification from Imugene when future announcements pertaining to these trials are made.
Yet with IMU I do think its simply of matter of time in the saddle. Or in the market as it were. The foundations are built and the pathway to success has been constructed by a collective of clinical geniuses with one goal in mind, to fight cancer and save lives. Stocks rise and fall like the tide, it’s simply a matter of picking those who are capable of rising above it. Here’s one of my real life examples of a stock that may be able to do so.
“Hit me up”, she said
Last year a protagonist on this thread suggested they were wary of individuals such as I who only followed one stock. When quizzed as to what other stocks I was or would be interested in, I made the comment Celularity was a share I was most impressed by. Well as luck would have it for the cynic, the Celularity (CELU) share price dumped in the ensuing weeks, and I’m confident they dined out at my expense for a few months. That said Celularity has since staged a recovery and is now trading at levels I had predicted back in the second half of 2021.
As with Imugene, I maintain it’s simply a matter of time.
DYOR - Best of Luck to all LTH’S - seek investment advice where applicable
(20min delay)